Heart FailureNCT06478732
HeartMed-HF Digital Therapeutics Improves Exercise Capacity in CHF Patients After AMI
A study testing health services in people with Heart Failure, run by The First Affiliated Hospital with Nanjing Medical University.
Trial summary
Chronic heart failure (HF) is a severe manifestation and terminal stage of various cardiovascular diseases, with high incidence and mortality rates. Myocardial infarction (MI) is currently one of the most common and significant causes of HF globally. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- health services
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 710 participants
- Where
- No sites listed yet
- Study dates
- 30 Jul 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be of either sex with age ≥ 18 years and ≤ 75 years.
- Hospitalization due to AMI (onset to randomization ≤ 2 weeks), including STEMI and NSTEMI.
- Meeting the diagnostic criteria for chronic HF, including:
- Symptoms and/or signs of heart failure; (2) LVEF (Simpson's method) < 50%, and NT-proBNP ≥ 125pg/mL before enrollment. 4. Patients must be willing to comply with the study protocol and give the informed consent.
Who cannot join
- Contraindications to cardiopulmonary exercise testing (bicycle ergometer) or 6-minute walking test.
- Pregnancy, breastfeeding, or planning pregnacy within 1 year.
- Patients who have undergone mechanical circulatory support (including intra-aortic balloon pump, Impella, ECMO, etc.) or endotracheal intubation.
- History of viral cardiomytis or non-ischemic cardiomyopathy including dilated cardiomyopathy, hypertrophic cardiomyopathy, perinatal cardiomyopathy, etc.
- Moderate to severe valvular heart disease or a history of valve replacement.
- Severe liver dysfunction [ALT ≥ 3 times the upper limit of normal range or renal dysfunction (eGFR<60 mL /min/1.73m2)].
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- Malignant tumors or other diseases, with expected life expectancy <1 year.
- Inability to use smartphones or communicate with the management team for any reason.
- Enrolled in other clinical trials.
- Any other clinical conditions unsuitable for this study by the investigator.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: HeartMed-HF Digital Therapeutics Improves Exercise Capacity in Patients With Chronic Heart Failure After Acute Myocardial Infarction: an International, Multi-center, Randomized Controlled Clinical Trial
Chronic heart failure (HF) is a severe manifestation and terminal stage of various cardiovascular diseases, with high incidence and mortality rates. Myocardial infarction (MI) is currently one of the most common and significant causes of HF globally. The occurrence of HF after MI significantly increases the mortality risk for patients. Actively controlling risk factors and strengthening outpatient management of HF patients post-MI are crucial for alleviating clinical symptoms and enhancing exercise capacity. Recently, digital health interventions (DHI) have shown promising potential in managing cardiovascular disease patients. However, the application in patients with HF post-MI has not been well-reported. Therefore, this study independently and innovatively designed the HeartMed-HF digital therapeutics to demonstrate its effectiveness and safety in patients with HF after MI.
Read the detailed description
Acute myocardial infarction (AMI) is caused by acute occlusion of the coronary artery and interruption of blood flow, which leads to myocardium necrosis in the blood supply area of the culprit vessel. AMI can lead to the loss of cardiomyocytes, which in turn causes ventricular enlargement, myocardial hypertrophy, eventually leading to the decline of cardiac function. In severe cases，AMI may even result in acute or chronic heart failure (HF). Patients with HF after MI have significantly decreased quality of life, high mortality and poor clinical prognosis. Studies have shown that the incidence of HF in patients with ST-segment elevation myocardial infarction (STEMI) is about 21.8%, and the 30-day mortality rate of patients with HF after MI is up to 25%. The occurrence of HF after MI is associated with various factors. Advanced age, hypertension, diabetes, renal insufficiency, rapid heart rate, atrial fibrillation (AF), low left ventricular ejection fraction (LVEF), stroke are all risk factors. Actively controlling these factors is crucial. However, due to the lack of medical knowledge, poor self-mobility among HF patients, outpatient management faces severe challenges. Therefore, strengthening outpatient management for patients with HF after MI is of great significance in alleviating clinical symptoms and improving patients' exercise capacity.
Recently, the digital health intervention (DHI) industry composed of internet, artificial intelligence (AI), mobile terminals and wearable devices has developed rapidly worldwide, which plays an important role in health care. DHI has shown promising prospects in the management of cardiovascular diseases. It can be used for AF screening, blood pressure management, and reducing mortality in HF patients, among other applications. However, the use in patients with HF after MI lacks large-scale evidence-based medical support.
Therefore, this study has independently designed the HeartMed-HF digital heart failure clinical management system for patients with HF after MI. The system monitors patients' weight, heart rate, blood pressure, fluid intake and output, and other HF evaluation indicators at home using wearable devices. Combining data from patients' medical histories, laboratory test results, and surgical records, the system uses AI algorithms to generate personalized outpatient HF management plans, achieving precise home-based clinical management for patients. The core management components include health education, symptom management, continuous monitoring, risk warning, medication management, and cardiac exercise rehabilitation. Additionally, the study will form a comprehensive clinical management team consisting of physician assistants, rehabilitation trainers, nutritionists, psychologists, and health managers. Through an internet platform and mobile terminals, the system closely connects patients and doctors, extending inpatient treatment to the home and realizing a closed-loop clinical management model that integrates real-time monitoring, early warning, and timely intervention.
- Conditions
- Heart Failure
- Being tested
- health services
- Keywords
- heart failure, acute myocardial infarction, digital therapeutics
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
health servicesOther
Implement comprehensive heart failure management for patients in the experimental group using the HeartMed-HF digital therapy
| Study group | Role | What they receive |
|---|---|---|
| the experimental group | Experimental | receive comprehensive heart failure management Receives: Other: health services |
| the controlled group | No intervention | receive the current outpatient follow-up management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak oxygen uptake (peak VO2）
Using cardiopulmonary exercise testing to measure peak VO2
Measured: 1 year
Secondary outcomes (8)
6-minute walking test
Using 6-minute walking test to evaluate exercise tolerance.
Measured: 1 year
Echocardiographic indexes
Left ventricular end-systolic volume (LVESV), left ventricular diastolic volume (LVEDV), left ventricular ejection fraction (LVEF).
Measured: 1 year
Cardiopulmonary exercise testing
Using cardiopulmonary exercise testing (cycle ergometer) to evaluate cardiac tolerance.
Measured: 1 year
Patient Health Questionnaire-9 (PHQ-9)
The PHQ-9 is a commonly used self-administered scale designed to assess the severity and frequency of depressive symptoms. It consists of 9 items covering common depressive symptoms, with each item scored from 0 to 3. The total score ranges from 0 to 27, where higher scores indicate more severe depressive symptoms.
Measured: 1 year
Generalized anxiety disorder-7 (GAD-7)
The GAD-7 is a commonly used self-administered scale designed to assess the severity and frequency of symptoms of generalized anxiety disorder over the past 2 weeks. It consists of 7 items covering common anxiety symptoms, with each item scored from 0 to 3. The total score ranges from 0 to 21, where higher scores indicate more severe anxiety symptoms.
Measured: 1 year
Clinical events
All-cause mortality, cardiovascular mortality and heart failure rehospitalization
Measured: 1 year
36-item short form health survey (SF-36)
The SF-36 Health Survey is a commonly used tool for assessing health-related quality of life, aiming to evaluate individuals' physical functioning and health perceptions. SF-36 consists of 36 questions covering 8 dimensions: Physical Functioning (PF), Role Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role Emotional (RE), and Mental Health (MH). Each question offers several options describing different health states, from which respondents choose the one that best fits their condition. Scores are calculated based on weighted allocations and specific algorithms, typically represented as numbers between 0 and 100. Higher scores indicate better health status for the respondent.
Measured: 1 year
Cost-effectiveness analysis
Patient follow-up 1-year total costs refer to all expenses accrued during a year-long monitoring period, encompassing medical services, medication treatments, laboratory tests, imaging studies, and other directly related healthcare and non-healthcare expenditures. These costs are considered as the cost (C) . The effectiveness (E) is defined as the proportion of patients who did not experience clinical events during the 1-year follow-up. The cost-effectiveness ratio (C/E) is computed based on this measure.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start30 Jul 2024 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 710 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunjian Li, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06478732
- Sponsor's protocol ID
- 031
- Status last verified
- Jul 2024
- First submitted
- 17 Jun 2024
- Last updated
- 16 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang H, Chai K, Du M, Wang S, Cai JP, Li Y, Zeng P, Zhu W, Zhan S, Yang J. Prevalence and Incidence of Heart Failure Among Urban Patients in China: A National Population-Based Analysis. Circ Heart Fail. 2021 Oct;14(10):e008406. doi: 10.1161/CIRCHEARTFAILURE.121.008406. Epub 2021 Aug 28.
PubMed 34455858Savarese G, Becher PM, Lund LH, Seferovic P, Rosano GMC, Coats AJS. Global burden of heart failure: a comprehensive and updated review of epidemiology. Cardiovasc Res. 2023 Jan 18;118(17):3272-3287. doi: 10.1093/cvr/cvac013.
PubMed 35150240Velagaleti RS, Pencina MJ, Murabito JM, Wang TJ, Parikh NI, D'Agostino RB, Levy D, Kannel WB, Vasan RS. Long-term trends in the incidence of heart failure after myocardial infarction. Circulation. 2008 Nov 11;118(20):2057-62. doi: 10.1161/CIRCULATIONAHA.108.784215. Epub 2008 Oct 27.
PubMed 18955667Cohen AB, Dorsey ER, Mathews SC, Bates DW, Safavi K. A digital health industry cohort across the health continuum. NPJ Digit Med. 2020 May 12;3:68. doi: 10.1038/s41746-020-0276-9. eCollection 2020.
PubMed 32411829Chen C, Ding S, Wang J. Digital health for aging populations. Nat Med. 2023 Jul;29(7):1623-1630. doi: 10.1038/s41591-023-02391-8. Epub 2023 Jul 18.
PubMed 37464029Vardas PE, Asselbergs FW, van Smeden M, Friedman P. The year in cardiovascular medicine 2021: digital health and innovation. Eur Heart J. 2022 Jan 31;43(4):271-279. doi: 10.1093/eurheartj/ehab874.
PubMed 34974610Perez MV, Mahaffey KW, Hedlin H, Rumsfeld JS, Garcia A, Ferris T, Balasubramanian V, Russo AM, Rajmane A, Cheung L, Hung G, Lee J, Kowey P, Talati N, Nag D, Gummidipundi SE, Beatty A, Hills MT, Desai S, Granger CB, Desai M, Turakhia MP; Apple Heart Study Investigators. Large-Scale Assessment of a Smartwatch to Identify Atrial Fibrillation. N Engl J Med. 2019 Nov 14;381(20):1909-1917. doi: 10.1056/NEJMoa1901183.
PubMed 31722151Kerwagen F, Koehler K, Vettorazzi E, Stangl V, Koehler M, Halle M, Koehler F, Stork S. Remote patient management of heart failure across the ejection fraction spectrum: A pre-specified analysis of the TIM-HF2 trial. Eur J Heart Fail. 2023 Sep;25(9):1671-1681. doi: 10.1002/ejhf.2948. Epub 2023 Jul 31.
PubMed 37368507Alshahrani NS, Hartley A, Howard J, Hajhosseiny R, Khawaja S, Seligman H, Akbari T, Alharbi BA, Bassett P, Al-Lamee R, Francis D, Kaura A, Kelshiker MA, Peters NS, Khamis R. Randomized Trial of Remote Assessment of Patients After an Acute Coronary Syndrome. J Am Coll Cardiol. 2024 Jun 11;83(23):2250-2259. doi: 10.1016/j.jacc.2024.03.398. Epub 2024 Apr 6.
PubMed 38588928McManus RJ, Little P, Stuart B, Morton K, Raftery J, Kelly J, Bradbury K, Zhang J, Zhu S, Murray E, May CR, Mair FS, Michie S, Smith P, Band R, Ogburn E, Allen J, Rice C, Nuttall J, Williams B, Yardley L; HOME BP investigators. Home and Online Management and Evaluation of Blood Pressure (HOME BP) using a digital intervention in poorly controlled hypertension: randomised controlled trial. BMJ. 2021 Jan 19;372:m4858. doi: 10.1136/bmj.m4858.
PubMed 33468518Victoria-Castro AM, Martin ML, Yamamoto Y, Melchinger H, Weinstein J, Nguyen A, Lee KA, Gerber B, Calderon F, Subair L, Lee V, Williams A, Shaw M, Arora T, Garcez A, Desai NR, Ahmad T, Wilson FP. Impact of Digital Health Technology on Quality of Life in Patients With Heart Failure. JACC Heart Fail. 2024 Feb;12(2):336-348. doi: 10.1016/j.jchf.2023.09.022. Epub 2023 Nov 8.
PubMed 37943227Dorje T, Zhao G, Tso K, Wang J, Chen Y, Tsokey L, Tan BK, Scheer A, Jacques A, Li Z, Wang R, Chow CK, Ge J, Maiorana A. Smartphone and social media-based cardiac rehabilitation and secondary prevention in China (SMART-CR/SP): a parallel-group, single-blind, randomised controlled trial. Lancet Digit Health. 2019 Nov;1(7):e363-e374. doi: 10.1016/S2589-7500(19)30151-7. Epub 2019 Oct 10.
PubMed 33323210Treskes RW, van Winden LAM, van Keulen N, van der Velde ET, Beeres SLMA, Atsma DE, Schalij MJ. Effect of Smartphone-Enabled Health Monitoring Devices vs Regular Follow-up on Blood Pressure Control Among Patients After Myocardial Infarction: A Randomized Clinical Trial. JAMA Netw Open. 2020 Apr 1;3(4):e202165. doi: 10.1001/jamanetworkopen.2020.2165.
PubMed 32297946
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HeartMed-HF Digital Therapeutics Improves Exercise Capacity in Patients With Chronic Heart Failure After Acute Myocardial Infarction: an International, Multi-center, Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06478732
- Acronym / sponsor ID
- 031
- Conditions
- Heart Failure
- Keywords
- heart failure, acute myocardial infarction, digital therapeutics
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 710 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 30 Jul 2024 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic heart failure (HF) is a severe manifestation and terminal stage of various cardiovascular diseases, with high incidence and mortality rates. Myocardial infarction (MI) is currently one of the most common and significant causes of HF globally. The occurrence of HF after MI significantly increases the mortality risk for patients. Actively controlling risk factors and strengthening outpatient management of HF patients post-MI are crucial for alleviating clinical symptoms and enhancing exercise capacity. Recently, digital health interventions (DHI) have shown promising potential in managing cardiovascular disease patients. However, the application in patients with HF post-MI has not been well-reported. Therefore, this study independently and innovatively designed the HeartMed-HF digital therapeutics to demonstrate its effectiveness and safety in patients with HF after MI.
Detailed description
Acute myocardial infarction (AMI) is caused by acute occlusion of the coronary artery and interruption of blood flow, which leads to myocardium necrosis in the blood supply area of the culprit vessel. AMI can lead to the loss of cardiomyocytes, which in turn causes ventricular enlargement, myocardial hypertrophy, eventually leading to the decline of cardiac function. In severe cases，AMI may even result in acute or chronic heart failure (HF). Patients with HF after MI have significantly decreased quality of life, high mortality and poor clinical prognosis. Studies have shown that the incidence of HF in patients with ST-segment elevation myocardial infarction (STEMI) is about 21.8%, and the 30-day mortality rate of patients with HF after MI is up to 25%. The occurrence of HF after MI is associated with various factors. Advanced age, hypertension, diabetes, renal insufficiency, rapid heart rate, atrial fibrillation (AF), low left ventricular ejection fraction (LVEF), stroke are all risk factors. Actively controlling these factors is crucial. However, due to the lack of medical knowledge, poor self-mobility among HF patients, outpatient management faces severe challenges. Therefore, strengthening outpatient management for patients with HF after MI is of great significance in alleviating clinical symptoms and improving patients' exercise capacity.
Recently, the digital health intervention (DHI) industry composed of internet, artificial intelligence (AI), mobile terminals and wearable devices has developed rapidly worldwide, which plays an important role in health care. DHI has shown promising prospects in the management of cardiovascular diseases. It can be used for AF screening, blood pressure management, and reducing mortality in HF patients, among other applications. However, the use in patients with HF after MI lacks large-scale evidence-based medical support.
Therefore, this study has independently designed the HeartMed-HF digital heart failure clinical management system for patients with HF after MI. The system monitors patients' weight, heart rate, blood pressure, fluid intake and output, and other HF evaluation indicators at home using wearable devices. Combining data from patients' medical histories, laboratory test results, and surgical records, the system uses AI algorithms to generate personalized outpatient HF management plans, achieving precise home-based clinical management for patients. The core management components include health education, symptom management, continuous monitoring, risk warning, medication management, and cardiac exercise rehabilitation. Additionally, the study will form a comprehensive clinical management team consisting of physician assistants, rehabilitation trainers, nutritionists, psychologists, and health managers. Through an internet platform and mobile terminals, the system closely connects patients and doctors, extending inpatient treatment to the home and realizing a closed-loop clinical management model that integrates real-time monitoring, early warning, and timely intervention.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the experimental group | Experimental | Other: health servicesreceive comprehensive heart failure management |
| the controlled group | No intervention | –receive the current outpatient follow-up management |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Be of either sex with age ≥ 18 years and ≤ 75 years.
- Hospitalization due to AMI (onset to randomization ≤ 2 weeks), including STEMI and NSTEMI.
- Meeting the diagnostic criteria for chronic HF, including:
- Symptoms and/or signs of heart failure; (2) LVEF (Simpson's method) < 50%, and NT-proBNP ≥ 125pg/mL before enrollment. 4. Patients must be willing to comply with the study protocol and give the informed consent.
Key exclusion criteria (10 listed)
- Contraindications to cardiopulmonary exercise testing (bicycle ergometer) or 6-minute walking test.
- Pregnancy, breastfeeding, or planning pregnacy within 1 year.
- Patients who have undergone mechanical circulatory support (including intra-aortic balloon pump, Impella, ECMO, etc.) or endotracheal intubation.
- History of viral cardiomytis or non-ischemic cardiomyopathy including dilated cardiomyopathy, hypertrophic cardiomyopathy, perinatal cardiomyopathy, etc.
- Moderate to severe valvular heart disease or a history of valve replacement.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| health servicesImplement comprehensive heart failure management for patients in the experimental group using the HeartMed-HF digital therapy | Other | the experimental group |
Primary outcome
Peak oxygen uptake (peak VO2）
Time frame: 1 year
Using cardiopulmonary exercise testing to measure peak VO2
8 secondary outcomes
6-minute walking test
Time frame: 1 year
Echocardiographic indexes
Time frame: 1 year
Cardiopulmonary exercise testing
Time frame: 1 year
Patient Health Questionnaire-9 (PHQ-9)
Time frame: 1 year
Generalized anxiety disorder-7 (GAD-7)
Time frame: 1 year
Clinical events
Time frame: 1 year
36-item short form health survey (SF-36)
Time frame: 1 year
Cost-effectiveness analysis
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
- Background: PubMed 34455858Wang H, Chai K, Du M, Wang S, Cai JP, Li Y, Zeng P, Zhu W, Zhan S, Yang J. Prevalence and Incidence of Heart Failure Among Urban Patients in China: A National Population-Based Analysis. Circ Heart Fail. 2021 Oct;14(10):e008406. doi: 10.1161/CIRCHEARTFAILURE.121.008406. Epub 2021 Aug 28.
- Background: PubMed 35150240Savarese G, Becher PM, Lund LH, Seferovic P, Rosano GMC, Coats AJS. Global burden of heart failure: a comprehensive and updated review of epidemiology. Cardiovasc Res. 2023 Jan 18;118(17):3272-3287. doi: 10.1093/cvr/cvac013.
- Background: PubMed 18955667Velagaleti RS, Pencina MJ, Murabito JM, Wang TJ, Parikh NI, D'Agostino RB, Levy D, Kannel WB, Vasan RS. Long-term trends in the incidence of heart failure after myocardial infarction. Circulation. 2008 Nov 11;118(20):2057-62. doi: 10.1161/CIRCULATIONAHA.108.784215. Epub 2008 Oct 27.
- Background: PubMed 32411829Cohen AB, Dorsey ER, Mathews SC, Bates DW, Safavi K. A digital health industry cohort across the health continuum. NPJ Digit Med. 2020 May 12;3:68. doi: 10.1038/s41746-020-0276-9. eCollection 2020.
- Background: PubMed 37464029Chen C, Ding S, Wang J. Digital health for aging populations. Nat Med. 2023 Jul;29(7):1623-1630. doi: 10.1038/s41591-023-02391-8. Epub 2023 Jul 18.
- Background: PubMed 34974610Vardas PE, Asselbergs FW, van Smeden M, Friedman P. The year in cardiovascular medicine 2021: digital health and innovation. Eur Heart J. 2022 Jan 31;43(4):271-279. doi: 10.1093/eurheartj/ehab874.
- Background: PubMed 31722151Perez MV, Mahaffey KW, Hedlin H, Rumsfeld JS, Garcia A, Ferris T, Balasubramanian V, Russo AM, Rajmane A, Cheung L, Hung G, Lee J, Kowey P, Talati N, Nag D, Gummidipundi SE, Beatty A, Hills MT, Desai S, Granger CB, Desai M, Turakhia MP; Apple Heart Study Investigators. Large-Scale Assessment of a Smartwatch to Identify Atrial Fibrillation. N Engl J Med. 2019 Nov 14;381(20):1909-1917. doi: 10.1056/NEJMoa1901183.
- Background: PubMed 37368507Kerwagen F, Koehler K, Vettorazzi E, Stangl V, Koehler M, Halle M, Koehler F, Stork S. Remote patient management of heart failure across the ejection fraction spectrum: A pre-specified analysis of the TIM-HF2 trial. Eur J Heart Fail. 2023 Sep;25(9):1671-1681. doi: 10.1002/ejhf.2948. Epub 2023 Jul 31.
- Background: PubMed 38588928Alshahrani NS, Hartley A, Howard J, Hajhosseiny R, Khawaja S, Seligman H, Akbari T, Alharbi BA, Bassett P, Al-Lamee R, Francis D, Kaura A, Kelshiker MA, Peters NS, Khamis R. Randomized Trial of Remote Assessment of Patients After an Acute Coronary Syndrome. J Am Coll Cardiol. 2024 Jun 11;83(23):2250-2259. doi: 10.1016/j.jacc.2024.03.398. Epub 2024 Apr 6.
- Background: PubMed 33468518McManus RJ, Little P, Stuart B, Morton K, Raftery J, Kelly J, Bradbury K, Zhang J, Zhu S, Murray E, May CR, Mair FS, Michie S, Smith P, Band R, Ogburn E, Allen J, Rice C, Nuttall J, Williams B, Yardley L; HOME BP investigators. Home and Online Management and Evaluation of Blood Pressure (HOME BP) using a digital intervention in poorly controlled hypertension: randomised controlled trial. BMJ. 2021 Jan 19;372:m4858. doi: 10.1136/bmj.m4858.
- Background: PubMed 37943227Victoria-Castro AM, Martin ML, Yamamoto Y, Melchinger H, Weinstein J, Nguyen A, Lee KA, Gerber B, Calderon F, Subair L, Lee V, Williams A, Shaw M, Arora T, Garcez A, Desai NR, Ahmad T, Wilson FP. Impact of Digital Health Technology on Quality of Life in Patients With Heart Failure. JACC Heart Fail. 2024 Feb;12(2):336-348. doi: 10.1016/j.jchf.2023.09.022. Epub 2023 Nov 8.
- Background: PubMed 33323210Dorje T, Zhao G, Tso K, Wang J, Chen Y, Tsokey L, Tan BK, Scheer A, Jacques A, Li Z, Wang R, Chow CK, Ge J, Maiorana A. Smartphone and social media-based cardiac rehabilitation and secondary prevention in China (SMART-CR/SP): a parallel-group, single-blind, randomised controlled trial. Lancet Digit Health. 2019 Nov;1(7):e363-e374. doi: 10.1016/S2589-7500(19)30151-7. Epub 2019 Oct 10.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing health services in people with Heart Failure, run by The First Affiliated Hospital with Nanjing Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chunjian Li, PHD (13701465229, lijay@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak oxygen uptake (peak VO2） (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06478732, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2024.